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GASTROFRENAL 200 mg HARD CAPSULES

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A doctor will review your case and decide whether a prescription is medically appropriate.

Talk to a doctor about this medicine

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Discuss your symptoms and possible next steps in a quick online consultation.

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use GASTROFRENAL 200 mg HARD CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introducción

Prospecto: información para el usuario

GASTROFRENAL 200 mg cápsulas duras

Cromoglicato de sodio

Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o farmacéutico.
  • Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
  • Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Gastrofrenal 200 mg cápsulas duras y para qué se utiliza
  2. Qué necesita saber antes de empezar a tomar Gastrofrenal 200 mg cápsulas duras
  3. Cómo tomar Gastrofrenal 200 mg cápsulas duras
  4. Posibles efectos adversos
  5. Conservación de Gastrofrenal 200 mg cápsulas duras
  6. Contenido del envase e información adicional

1. Qué es Gastrofrenal 200 mg cápsulas duras y para qué se utiliza

Gastrofrenal está indicado en las alergias alimentarias y en el tratamiento de los síntomas asociados a la liberación de mediadores mastocitarios (mastocitosis y síndromes de activación mastocitarios) en adultos, adolescentes y niños con peso igual o superior a 40 kg.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a tomar Gastrofrenal 200 mg cápsulas duras

No tome Gastrofrenal 200 mg cápsulas duras:

  • Si es alérgico al cromoglicato de sodio o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a tomar este medicamento.

En el tratamiento de alergias alimentarias, cualquier reintroducción en la dieta de un alimento alergénico, sólo se realizará bajo estricto control médico.

Si está usted tomando medicamentos denominados corticoides orales, consulte con su médico antes de tomar este medicamento, ya que tendrá que ajustar la dosis de su medicación.

Niños y adolescentes

El tratamiento de la mastocitosis con cromoglicato en niños deberá realizarse sólo en aquellos casos en que el médico lo considere necesario como cuando se presenten síntomas graves que requieran tratamiento intensivo.

Mayores de 65 años

Deberá tenerse en cuenta la presencia de otras enfermedades concomitantes. En caso de alteraciones en la función renal o hepática, su médico podrá ajustarle la dosis de este medicamento.

Si sufre usted una reacción alérgica debe interrumpir definitivamente el tratamiento.

Si sufre cualquier otra reacción adversa, interrumpa el tratamiento y acuda al médico. Su médico le indicará como reanudar el tratamiento con Gastrofrenal.

Pacientes con insuficiencia renal o hepática

Si tiene usted insuficiencia renal o hepática, acuda a su médico para que le ajuste la dosis del medicamento.

Toma de Gastrofrenal 200 mg cápsulas duras con otros medicamentos

Comunique a su médico o farmacéutico si está tomando, ha tomado recientemente o podría tener que tomar cualquier otro medicamento.

Aunque no se han descrito interacciones con otros medicamentos, aun así se recomienda espaciar las tomas de cromoglicato de otros medicamentos.

Toma de Gastrofrenal 200 mg cápsulas duras con alimentos, bebidas y alcohol

Este medicamento debe administrarse con el estómago vacío. Puede ingerir alimentos una vez hayan pasado 30 minutos desde la toma del medicamento o 2 horas antes de la administración de este medicamento.

Embarazo, lactancia y fertilidad

Si está embarazada o en período de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

No hay datos del tratamiento con este medicamento en mujeres embarazadas, por ello debe evitarse la toma del mismo durante el embarazo salvo que su médico lo considere estrictamente necesario. Las mujeres que deseen quedarse embarazadas deberán consultar a su médico.

No existen datos sobre la excreción de cromoglicato de sodio en la leche materna. Las mujeres en período de lactancia, deben consultar al médico antes de tomar este medicamento.

Conducción y uso de máquinas

No es probable que este medicamento afecte a su capacidad de conducir y utilizar máquinas.

3. Cómo tomar Gastrofrenal 200 mg cápsulas duras

El tratamiento con este medicamento solo puede iniciarlo y supervisarlo un médico experimentado en el manejo de estas enfermedades.

Su médico le indicará la dosis recomendada para usted, a modo de recomendación:

  1. Tratamiento de alergias alimentarias

-Dosis inicial:

Adultos:

1 cápsula de 200 mg 4 veces al día, antes de las comidas.

Adolescentes y niños con peso ≥ 40 kg:

10 a 15 mg/kg de peso y día repartidos en 4 tomas, antes de las comidas.

Si no se consigue un control satisfactorio al cabo de 2 ó 3 semanas, la dosificación puede ser aumentada, hasta 1500 mg/día en adultos y hasta 20 mg/kg/día en niños.

-Dosis de mantenimiento:

Una vez conseguida la respuesta terapéutica, la dosis debe reducirse a la mínima necesaria para mantener al paciente libre de síntomas.

  1. Síntomas asociados a la liberación de mediadores mastocitarios (mastocitosis y síndromes de activación mastocitaria)

El tratamiento debe ser individualizado y adaptado a cada paciente. Su médico le indicará qué dosis y cómo tomar este medicamento. No obstante, la dosis habitual es la siguiente:

-Dosis inicial:

Adultos:

Los 2 primeros días del tratamiento se administrarán solamente 200 mg al día, por la noche. Si la tolerancia es buena, durante los días 3 y 4 del tratamiento, se podrá aumentar la dosis a 400 mg repartidos en 2 tomas (200 mg al acostarse y 200 mg por la mañana). Si la tolerancia es buena, se seguirá el tratamiento con la dosis habitual de 200 mg 4 veces al día.

Adolescentes y niños con peso ≥ 40 kg:

Durante los primeros días de tratamiento, deberán seguirse las mismas indicaciones dadas para los adultos.

La pauta más adecuada sería: durante los 2 primeros días administrar solamente 100 mg al día, por la noche. Si la tolerancia es buena, durante los días 3 y 4 de tratamiento, se podrá aumentar la dosis a 200 mg, repartidos en 2 tomas (100 mg al acostarse y 100 mg por la mañana). Si la tolerancia es buena, se seguirá el tratamiento con la dosis habitual calculada en función del peso (10 a 15 mg/kg de paso al día) repartida siempre en 4 tomas diarias.

Para esta población pudiera resultar más adecuada la otra presentación de este medicamento, Gastrofrenal 100 mg cápsulas duras,con una dosis menor.

-Dosis de mantenimiento:

Adultos:

200 mg (1 cápsula) 4 veces al día, antes de las comidas.

Adolescentes y niños con peso ≥ 40 kg:

10 a 15 mg/kg de peso al día repartido en 4 tomas.

Si no se consigue un control satisfactorio de los síntomas al cabo de 2 o 3 semanas, su médico puede aumentar la dosis, hasta 1500 mg al día en adultos y hasta 20 mg/kg peso/día en niños, siempre repartidos en 4 tomas.

Forma de administración

Este medicamento se toma por vía oral.

Debe tomar las cápsulas con un vaso de agua y con el estómago vacío. Tome el medicamento 30 minutos antes de comer o 2 horas después de comer.

En caso de que se produzcan reacciones adversas o no observe mejoría en los síntomas de la enfermedad, deberá acudir al médico, ya que puede ser necesario un ajuste de dosis.

Si toma más Gastrofrenal 200 mg cápsulas duras del que debe

En caso de sobredosis o ingestión accidental, consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, Teléfono (91) 562 04 20, indicando el medicamento y la cantidad ingerida.

Si olvidó tomar Gastrofrenal 200 mg cápsulas duras

No tome una dosis doble para compensar las dosis olvidadas.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Aunque este medicamento es normalmente bien tolerado, se han descrito en algunos casos reacciones alérgicas graves, especialmente cuando se utiliza por vía inhalatoria. Si experimenta síntomas de anafilaxia (hinchazón de la cara, lengua, ojos, dificultad para respirar) deje de tomar inmediatamente el medicamento.

Se han notificado las siguientes reacciones adversas, de frecuencia no conocida (no puede estimarse a partir de los datos disponibles).

  • dolor de cabeza, ansiedad, irritabilidad, cambios de humor, trastornos del sueño.
  • dolor en la zona superior del abdomen, náuseas, cólicos abdominales, estreñimiento, diarrea, dispepsia.
  • erupción, picor.
  • dolor muscular, dolor de las articulaciones y cansancio moderado.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano www.notificaRAM.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de Gastrofrenal 200 mg cápsulas duras

Mantener fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de “CAD”. La fecha de caducidad es el último día del mes que se indica.

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que ya no necesita en el punto Sigre de la farmacia. En caso de duda, pregunte a su farmacéutico cómo deshacerse de los envases y los medicamentos que no necesita. De esta forma ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Angileptol sabor menta

Cada comprimido contiene:

  • Los principios activos:

Clorhexidina dihidrocloruro, 5 mg

Benzocaína, 4 mg

Enoxolona, 3 mg

  • Los demás componentes (excipientes) son: sorbitol (E420), acesulfamo potásico (E950), estearato de magnesio y aroma de menta

Aspecto del producto y contenido del envase

Angileptol son comprimidos para chupar, de color blanco, redondos y con la letra griega σ en una de las caras.

Se presenta en envases que contienen 15 y 30 comprimidos para chupar.

Otras presentaciones

Angileptol Sabor menta-eucalipto

Angileptol Sabor miel-limón

Titular de la autorización de comercialización

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona. España

Responsable de la fabricaciónPharmaloop, S.L

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid). ESPAÑA

o

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Roma). ITALIA

Fecha de la última revisión de este prospecto:Septiembre 2021

Otras fuentes de información

La información detallada de este medicamento está disponible en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es

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Family medicine 18 years exp.

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Frequently Asked Questions

Is a prescription required for GASTROFRENAL 200 mg HARD CAPSULES?
GASTROFRENAL 200 mg HARD CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in GASTROFRENAL 200 mg HARD CAPSULES?
The active ingredient in GASTROFRENAL 200 mg HARD CAPSULES is cromoglicic acid. This information helps identify medicines with the same composition but different brand names.
How much does GASTROFRENAL 200 mg HARD CAPSULES cost in pharmacies?
The average pharmacy price for GASTROFRENAL 200 mg HARD CAPSULES is around 93.67 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures GASTROFRENAL 200 mg HARD CAPSULES?
GASTROFRENAL 200 mg HARD CAPSULES is manufactured by Alfasigma Espana S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of GASTROFRENAL 200 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether GASTROFRENAL 200 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to GASTROFRENAL 200 mg HARD CAPSULES?
Other medicines with the same active substance (cromoglicic acid) include GASTROFRENAL 100 mg HARD CAPSULES, ASACOL 1 G SUPPOSITORIES, ASACOL 1600 mg GASTRO-RESISTANT TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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